The present invention relates to ingestible pharmaceutical compositions comprising pharmaceutical actives useful for treating upper gastrointestinal tract distress and 3-1-menthoxy propane 1,2-diol ("MPD") in amounts effective for providing a cooling sensation in the throat.
Pharmaceutical compositions, such as antacids, useful for treating upper gastrointestinal tract distress (such as heartburn, indigestion, stomachache, etc.) are widely used. They vary depending on the active ingredients, and increasingly differ in the flavors, texture and even forms. The excipients for such compositions are chosen not only as appropriate for the dose form, but also to provide the best possible aesthetics for the compositions, including texture, flavor, after-taste, etc. Depending on the active used, and to some extent the excipients utilized, the time for the therapeutic effect of the active ingredient to be meaningful to the consumer will vary. Frequently, however, the time when the consumer actually begins to receive the benefit of the active ingredient and the time when the consumer perceives the product as starting to "work" are different. Dose form, flavorants, texture, etc. probably all contribute at least in part to this perception. Obviously, for the consumer in need of relief for upper gastrointestinal tract distress, perceiving that the product is working as quickly as possible after ingestion is of great benefit in addition to the true therapeutic relief eventually provided by the active ingredient.
In spite of the large amount of research directed to providing faster acting compositions for treating upper gastrointestinal distress, there continues to be a need for compositions which not only do act faster but also which are perceived by consumers as working faster. Surprisingly, it has been discovered that including the coolant MPD (which is very effective for providing a cooling sensation to the throat) results in the perception by the consumer that the pharmaceutical composition is working. Thus, while this coolant has no apparent therapeutic activity, the signal it provides to the consumer in need of fast relief of upper gastrointestinal distress is of great benefit for the perception that relief is already being provided. Even more surprising is that this improved signal of relief is recognized when compositions according to the present invention are compared against similar compositions containing menthol (which has a noticeably different cooling profile from MPD).
Thus, it is an object of the present invention to provide ingestible pharmaceutical compositions containing a pharmaceutical active useful for treating upper gastrointestinal tract distress (e.g., upset stomach, heartburn, indigestion) which are perceived as providing faster relief and/or greater perceived efficacy and/or longer duration of activity. Furthermore, an object is to provide methods for treating upper gastrointestinal distress by administering pharmaceutical compositions according to the present invention.
These and other objects of the present invention will become readily apparent from the detailed description which follows.
All percentages and ratios used herein are by weight, and all measurements are made at 25.degree. C., unless otherwise specified.